RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-07-04

Brief Summary

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The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.

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Detailed Description

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The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).

Conditions

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Cognitive Therapy Depression, Postpartum Mental Health Depression Depressive Disorder Anxiety Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Smartphone use + treatment as usual

Participants will receive treatment as usual and use the smartphone app for the management of mood.

Group Type EXPERIMENTAL

Use of smartphone application (app)

Intervention Type BEHAVIORAL

Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.

Treatment as usual

Intervention Type OTHER

Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.

Treatment as usual

Participants will receive treatment as usual.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.

Interventions

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Use of smartphone application (app)

Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.

Intervention Type BEHAVIORAL

Treatment as usual

Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Postpartum day 0-7 after delivery
* Medically stable and cleared for discharge
* Owns smartphone
* English-speaking (because all intervention materials are in English)